by Jeremy Moore | May 6, 2024 | Cybersecurity, International Regulatory Requirement, Software as a Medical Device, US FDA Regulatory Requirements
Safeguarding SaMDs in an Evolving Cybersecurity LandscapeWhy Cybersecurity for SaMD Companies MattersUnraveling the Ramifications: The Dark Side of Technological Progress in SaMDThe Escalating Importance of Cybersecurity for SaMD CompaniesCommon Cyber Threats...
by Jeremy Moore | Apr 17, 2024 | Product Development, Software as a Medical Device
Exploring the Intersection: Agile Methodologies in Medical Device Software DevelopmentUnderstanding Traditional Development MethodsIntroduction to AgileChallenges of Implementing Agile in Medical Device Software DevelopmentImplementing Agile in Medical Device...
by Jeremy Moore | Mar 25, 2024 | Software as a Medical Device
Defining Software as a Medical DeviceRegulatory Considerations and Exclusions of SaMDBridging the Gap Between Software Development and Regulatory ComplianceDetermining Whether Your Product Qualifies as Software as a Medical Device (SaMD)First, let’s address the...
